Method for maintenance of urethral catheters

ABSTRACT

A method for insertion, maintenance, and removal of urethral catheters in mammals including humans includes steps for preventing or reducing the incidence of catheter associated urinary tract infections. In addition to sterile procedures currently practiced or as may be practiced in the future in connection with catheter use, the method includes the steps of applying an antiseptic, zwitterionic, and acidic skincare solution capable of preserving the stratum corneum to the perineum, meatus, and contiguous mucosa surrounding the insertion site before insertion, after insertion, periodically during the period of indwelling, in connection with any incidence of incontinence, and, optionally, before and after removal of the catheter. Application of the solution optionally is continued after catheter removal on a periodic basis until the threat of an infection associated with catheter use has passed, typically at least about five (5) to seven (7) days and up to thirty (30) days. The solution pH is desirably from about 4.4 to 5.5.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application Ser.No. 61/943,287, which was filed in the United States Patent andTrademark Office on Feb. 21, 2014, and is entitled Method forMaintenance of Urethral Catheters, Including Steps up to and afterCatheter Removal; and also claims the benefit of U.S. ProvisionalApplication Ser. No. 62/082,019, which was filed in the United StatesPatent and Trademark Office on Nov. 19, 2014, and is entitled Method forthe Prevention and Treatment of Acne; and which incorporates byreference each of these Provisional applications in their entirety.

FIELD OF THE INVENTION

This invention relates to methods for reducing the incidence andseverity of catheter-acquired urinary tract infections, also known bythe acronym CAUTI's, arising from urethral catheter use, especiallyprolonged use of indwelling catheters in a hospital or other caresetting.

BACKGROUND OF THE INVENTION

Urinary catheters are frequently used in many different areas ofhospitals from Intensive Care Units to Labor and Delivery. Hospitalsimplement sterile protocols specific to urinary catheters to reduce therisk that a patient will develop a hospital-acquired andcatheter-associated urinary tract infection. However, CAUTI's remain asignificant and costly type of hospital acquired infection (“HAI”) andthe reasons for CAUTI's are thought to be multifactorial, includingpatient risk factors, nursing behaviors, data analysis, dailysurveillance, catheter materials, and cleansing products.

According to an article written by Dr. Evelyn Lo, M.D. and othersentitled “Strategies to Prevent Catheter-Associated Urinary TractInfections in Acute Care Hospitals,” published in the October 2008 issueof the magazine Infection Control and Hospital Epidemiology by TheUniversity of Chicago Press, page S41, urinary tract infections are themost common of all hospital acquired infections, and 80% of urinarytract infections are attributable to indwelling urethral catheters. TheJanuary 2002 issue of the same magazine, in an article by Paul A.Tambyah, MBBS and others entitled “The Direct Costs of NosocomialCatheter-Associated Urinary Tract Infection in the Era of Managed Care”reports at page 27 that, regardless of the sterile protocols developedfor catheter use, CAUTI's still account for more than one millioninfections in U.S. hospitals each year. Those one million infectionsresult in approximately 13,000 deaths a year from urinary tractinfections, according to the Centers for Disease Control as reported intheir Device-associated Module CAUTI, published in January 2014. Urinarycatheters are not only associated with mortality due to CAUTI's, buturinary catheters are also associated with other negative outcomesincluding nonbacterial urethral inflammation, urethral strictures,medical trauma, morbidity, longer hospital stays, and increasedantibiotic use.

Up to half of patients that require the use of an indwelling urethralcatheter for five days or longer will develop bacteriuria or candiduria,as reported in “The Direct Costs of Nosocomial Catheter-AssociatedUrinary Tract Infection in the Era of Managed Care,” which was publishedby The University of Chicago Press in the January 2002 issue ofInfection Control and Hospital Epidemiology. Candiduria is commonlythought of as a yeast infection. Bacteriuria is the presence of bacteriain the urine that is not associated with urine sample collection. Thereis a significant danger posed to hospitals by CAUTI's attributed to thepresence of bacteriuria because bacteriuria may include a largereservoir of antibiotic-resistant organisms including yeasts,methicillin-resistant staphylococcus aureus, vancomycin-resistantenterococci, and multi-resistant, extended spectrumbeta-lactamase-producing gram-negative bacteria.

CAUTI's not only produce negative health outcomes for patients, butresult in large financial costs on the order of thirty billion dollarsannually according to the non-profit Committee to Reduce InfectionDeaths in the web-based article “What is RID?” 2013 available from theworld wide web at the file “objective” for the site entitled“hospitalinfection” and having the top level domain name “.org” and thefile extension SHTML. As more bacteria and other microorganisms becomedrug-resistant, the human and financial costs can be expected toincrease. Hospitals may be expected to bear the expense alone or to usecost shifting or other means to pass this cost along to patients as anuninsured additional cost. As of 2008, the Centers for Medicare andMedicaid Services stopped reimbursing hospitals for the additional costsof care for patients who develop CAUTI's during hospitalization, in partas an incentive to implement steps to reduce the cost of care.

Given the severity of the problem with CAUTI's from both the human andeconomic loss perspectives, methods and devices have been developed totry to reduce and to combat CAUTI's. Practice in the field has focusedon three areas: 1) treating the area of insertion, typically beforeinsertion, with an antiseptic, typically an aqueous solution of povidoneand iodine solution, usually a 10% solution and most commonly one of theBetadine® brand antiseptic solution formulations; 2) treating thecatheter device, which includes making the catheter out of antimicrobialmaterials or applying antimicrobial or antiseptic substances to theinterior or exterior surface of the catheter, including, for exampleBetadine®, and 3) treating the bladder and bladder contents to preventor reduce CAUTI's, typically with antimicrobial compounds, includingTauroldine.

Maintenance of the urethral catheter presents unique issues at least inpart due to the nature of the surrounding tissues, which includes themore delicate skin of the perineum, urinary meatus, and contiguousmucosa. Hospitals typically employ a sterile procedure for catheterinsertion, which includes wiping down the catheter and pre-treating thearea where the urethral catheter is to be inserted with an antisepticcompound, usually a povidone-iodine solution such as Betadine®. The 2009Guidelines for Prevention of Catheter-Associated Urinary TractInfections published by the Centers for Disease Control (“CDC”)specifically notes that there is no documented benefit of antisepticcleaning regimens before or after catheterization to prevent CAUTI's, ascompared to sterile water. Given the high rate of CAUTI's that occur inU.S. hospitals, the common sterile procedures that use antisepticsappear to do little to reduce infection rates as compared to water.

Problems arise in part due to the nature of hospital and emergency roompractice. Emergency room procedures are rarely done under idealconditions, but can influence outcomes much later in a patient'shospital stay. A focus on the immediate, life-sustaining needs of apatient may preclude consideration of longer-term consequences. The paceof emergency room care can result in shortcuts being taken by precludingtaking the time to fully follow a recommended protocol before moreurgent matters are addressed. For example, incoming patients may alreadyhave a urinary tract infection (“UTI”) on arrival and under idealconditions a protocol would be followed to confirm an existing UTI.Sometimes this step is skipped. Betadine® solutions should be allowed todry for three minutes, which may be too long in an emergency situation,resulting in poor aseptic technique when inserting a catheter. Somepatients may not even need a catheter, at least not immediately, andother options may be available for urination. The tendency tocatheterize emergency room patients can be further complicated by use ofan inappropriate size catheter, rushing to insert the catheter, poorcatheter placement, and other factors. Individual intensive care unitsmay have widely varying CAUTI rates as a result and the rates mayfluctuate. Increased rates of CAUTI's tend to come in clusters.

Another technique for reducing the opportunity for infection has been tomake the catheter body out of antimicrobial materials or to coat thecatheters with an antimicrobial substance, including for example,silver. On page 39 of the studies cited by the CDC Guidelines referencedabove, silver alloy-coated Foley catheters reduced the risk ofasymptomatic bacteriuria compared to a standard latex catheter. Theresults were more pronounced when the silver coated catheter wasindwelling in patients that had to be catheterized for less than oneweek. However, using a catheter for such a short time frame may not be aviable option for all patients. The 2009 CDC Guidelines refer to “low orvery low quality evidence” that suggests a benefit in using anantimicrobial or antiseptic-impregnated Foley catheter and recommendsfurther research.

Once the catheter is inserted, another treatment method proposes thatinfections can be treated by irrigating the catheter with anantimicrobial compound, or instilling the bladder with the antimicrobialcompound through the catheter. Some of the suggested methods useTauroldine, which has antimicrobial properties and can decreaseinfection rates, but produces intense pain in most tissues atconcentrations as low as about 10 mg/ml. Tauroldine is not generallyconsidered a viable option for patients that are conscious duringtreatment.

The Infectious Disease Society of America published in March of 2009guidelines for the diagnosis, prevention, and treatment ofCatheter-Associated Urinary Tract Infection in adults that discouragesroutine catheter irrigation with antimicrobials for the purpose ofcontrolling CAUTI's in patients with indwelling catheters. TheGuidelines on page 628 note that the data are said to be insufficient torecommend bladder irrigation to reduce CAUTI's. The CDC makes a similarrecommendation in their 2009 Guidelines, mentioned above.

Cleansing compounds are problematic for reducing CAUTI's. Many commonlyused cleansing compounds are too harsh for the delicate perineal skin,urinary meatus, and mucosa surrounding the insertion site. Generallyspeaking, antiseptic compounds, including povidone-iodine solution,alcohol, and chlorohexadrine, among others, and even soap and water, aresomewhat harsh and their use can be problematic. Alcohol andchlorohexadrine are not recommended for use on delicate mucosa or on theperineum. Although most all of these compounds are capable of reducingpotential contaminants, these compounds may actually contribute tosubsequent infections by drying the skin or establishing a basic pH,whereas normal skin has a somewhat acidic pH and moisture content thatserves a barrier function by limiting growth of microorganisms. Basic pHis believed to promote the growth of microorganisms, particularly whenthe antimicrobial ingredients have been reduced in effectiveness overtime. Stripping the skin of its naturally occurring and protectivelipids is believed to create chemical micro-abrasions and cause moistureloss through the epidermis, drying the skin. Contaminants may morereadily enter dry, torn skin and cause infection under these conditions.Specialty lotions may be applied to restore the skin, but normally arenot as effective as healthy skin.

Despite current methods and devices for reducing CAUTI's, the number ofinfections and the costs of treatment remain high and problematic forpatients and hospitals. The multifactorial nature of the CAUTI problemmakes resolution difficult. Still, it would be desirable to developimproved methods for reducing CAUTI's to more manageable levels, whichimproved methods are less troublesome and more efficient for hospitalpersonnel to accept and implement compared to existing protocols andthat are more readily accepted by patients.

SUMMARY OF THE INVENTION

The invention relates to improvements in methods for reducing thefrequency of catheter-associated urinary tract infections, commonlyreferred to by the acronym CAUTI's, which improvements include easilyimplemented steps for initially decolonizing the delicate perineum, theurinary meatus, and the contiguous mucosa surrounding the catheterinsertion site and maintaining these delicate areas in a state thatresists infection. The method includes the steps of pre-treatment of theperineum, urinary meatus, mucosa, and the exterior portions of thecatheter with a fast-drying antiseptic skin care solution both beforeand immediately after catheter insertion, followed by continualmaintenance treatments with the solution at regular intervals of fromabout 4 to 12 hours for maintenance of the perineum and exposed portionsof the catheter. In addition, treatment is performed after eachincidence of bowel incontinence. In some embodiments, treatment is alsoperformed immediately before catheter withdrawal and the perineum,urinary meatus, and contiguous mucosa wiped with soft, lint free clothimpregnated with the solution immediately after withdrawal. Stillfurther embodiments may include post-withdrawal maintenance treatmentsteps in which the perineum, urinary meatus, and mucosa are continuallywiped at regular intervals for a sufficient period of time afterwithdrawal to reduce or preclude infection attributable to the use of acatheter. Typically, this maintenance step is performed by patientself-care after discharge from a hospital for about five to seven days.It should be understood that patients include pets and other mammalsthat may be catheterized and that patient self-care is performed by acaregiver.

It should be recognized that by “antiseptic” is meant a substance thatkills and prevents growth and reproduction of bacteria, protozoa, yeast,fungi, and viruses. The term “antiseptic” is sometimes used synonymouslywith “antimicrobial,” which is how we used the term here. Antisepticsand antimicrobials should be distinguished from antibiotics, which killbacteria.

The method of the invention benefits from the use of antimicrobial andantiseptic compounds that typically do not significantly alter the pH ofnormal skin and support the stratum corneum, in themselves not strippingthe skin of lipids or moisture or causing micro-abrasions or tears inthe skin and contiguous mucosa. The invention is based at least in parton the recognition that, in addition to or even in place of thetreatment that is commonly practiced on sterile insertion of thecatheter and during catheter use, especially after an incidence of bowelincontinence, additional treatments are necessary to perform continuallyat regular intervals to cleanse and to maintain the catheter insertionsite throughout use.

Most CAUTI's occur after a period of indwelling of 4 to 5 days,indicating that the primary source of many infections is maintenance,not insertion. The initial cleansing and reduction in infectious agents,along with cleansing after contaminating events, is sometimes referredto as “primary decolonization,” and maintenance of the skin thereafter,or at least until the next primary decolonization event, is sometimesreferred to as “secondary decolonization.” Particularly for patientswith indwelling urinary catheters for an extended period of time, offive days or more, an initial primary decolonization followed bysecondary decolonization multiple times throughout and after use for aminimum period of time, with occasional additional primarydecolonization after a contaminating event, with the cleansers used inaccordance with the invention, should greatly reduce incidence ofCAUTI's.

It is believed that withdrawal of the catheter could result in microtears or abrasions in the urethra that can facilitate infection and thatcontinual treatment of the insertion area is desirable following removalof the catheter for a period of time sufficient to promote healing andto reduce or preclude the possibility of infection by promoting theskin's natural defenses, in addition to cleansing and reducing or atleast not promoting the growth of potentially infectious microbes.

Thus, solutions used in connection with decolonizing and maintenance ofa urinary catheter insertion site should typically be those thatpreserve the barrier function of the skin, including, minimally,moisture content, lipids, and mildly acidic pH, in addition to having anantimicrobial or antiseptic quality. It is thus desirable to use lessharsh antimicrobial or antiseptic compounds that do not damage the skinand contiguous mucosa, that promote a pH level similar to that of normalskin, and that preserve moisture and lipids, although it is believedthat the method of the invention could be practiced with other types ofcompounds, if permitted. It should be recognized that some commonantiseptic compounds are not recommended for use on the perineum, amongthem alcohol and chlorohexadine. Use of such compounds may not beequivalent to those less harsh treatments that preserve the naturalbarrier function of the skin and mucosa.

Although the invention may be practiced with current sterile insertiontechniques that normally rely on at least pre-insertion wiping of theperineum and catheter body with sterile water, povidone-iodine solution,or equivalent antiseptic solutions, it is believed that treatment solelywith the method set forth herein in a sterile manner following insertionprotocol, may be sufficient to accomplish sterile insertion. Thereafter,sterile methods may be practiced as advised and as reasonablyaccomplished by the patient after catheter withdrawal, which may includetreatment outside the hospital and in the home setting.

Preferably, the pH of the skincare solution used in the practice of themethod of the invention is acidic, and should not be so low as to bepainful of application nor so high as to promote infection. A preferredsuitable range of pH is from about 4.4 to 5.5. The solution ispreferably zwitterionic so as not to strip naturally occurring andprotective lipids from the skin, allowing the skin to stay hydrated. Thesolution should be antimicrobial and antiseptic and will typically benon-antibiotic, unnecessary antibiotic use contributing to resistance inbacteria strains. It is especially useful if the solution is capable ofmaintaining the balance of flora associated with normal skin, even asthe flora is reduced. It is also desirable that the solution be easilyabsorbed through the epidermis and at least into the deep layers of thedermis in the absence of creating micro-abrasions that can provide anentry point for infectious agents. One example of a cleansing solutionfor use in the practice of the invention is THERAWORX® brand skincleanser available from Avadim Technologies, Inc. in Asheville, N.C.THERAWORX® and similar skin cleansers are described in U.S. Pat. No.6,358,516, the contents of which are incorporated herein by reference intheir entirety.

Thus, the invention provides an easily implemented method for reducingCAUTI rates including steps of pretreatment, maintenance treatment, and,optionally, treatment on catheter withdrawal and maintenance thereafterfor a limited time, by applying an antiseptic skin care solution that isfast drying, that dries within as little as 30 seconds, and that iscapable of cleansing the delicate perineum and mucosa surrounding thecatheter insertion site by decolonizing infectious microbes andmaintaining the natural barrier properties of the skin over time.

BRIEF SUMMARY OF THE DRAWINGS

Having described the invention in general terms, reference will now bemade to the following drawings:

FIG. 1 is a flow diagram of the basic steps of the practice of themethod of the invention for the reduction of catheter acquiredinfections;

FIG. 2 is a highly schematic exploded perspective view of a section ofthe skin's layers;

FIG. 3 illustrates the frequency of CAUTI's per 1000 days for the methodof the invention compared to existing protocols, taken from a hospitalquality improvement project;

FIG. 4 is a statistical process control u-chart, which illustrates ratesof CAUTI's over time from a Poisson distribution, taken from a hospitalquality improvement project;

FIG. 5 illustrates intervals of time between CAUTI's, taken from ahospital quality improvement project; and

FIG. 6 is a statistical process control u-chart, which illustrates ratesof CAUTI's over time from a Poisson distribution, taken from a differenthospital quality improvement project of that illustrated in FIG. 4.

DETAILED DESCRIPTION OF THE INVENTION

The invention will now be described more fully hereinafter withreference to the drawings summarized above in which are illustratedsome, but not all, of the concepts of the invention. Indeed, theinvention may be embodied in many different forms and should not beconstrued as limited to the specific embodiments set forth herein;rather, the embodiments provided in this disclosure are intended tosatisfy applicable legal requirements.

FIG. 1 illustrates generally the method steps used in the practice ofthe invention. In the first step, step number 10, a skin cleansingsolution is applied in accordance with the invention to the skin,including the contiguous mucosa, and, optionally and preferably, to thecatheter. The catheter typically is sterile; however upon insertion theotherwise sterile catheter may carry infectious microbes into theurethra and bladder. Wiping the catheter with an antisepticantimicrobial agent is thus preferable. The cleansing solution ispreferably also an aqueous solution that is zwitterionic and of acidicpH, so as to preserve the barrier and moisture retention properties ofoutermost layer of skin. The catheter is wiped with a soft, lint-freecloth that has been saturated with the skin cleansing solution.

The area surrounding the insertion site, typically referred to as theperineum, and including the urinary meatus and contiguous mucosa, isalso wiped with a soft, lint-free cloth that is saturated with the skincleansing solution. It should be recognized that when referring to thearea surrounding the insertion site for a urethral catheter as “skin,”we also mean to include the contiguous exposed mucosa. It is helpful toprovide focused attention to wiping the meatus, which is the entrance tothe urethra and is the opening through which urine exits the body. As ageneral rule, wiping is accomplished front-to-back for women and inconcentric circles around glans penis for men. The solution normallyshould be allowed to dry for thirty seconds and is not rinsedthereafter.

It should be recognized that in a typical sterile insertion technique ofthe prior art, the perineum is cleansed with soap and water and then a10% povidone-iodine solution, often Betadine® brand solution, is appliedto the perineum, including the meatus. It is desirable that thepovidone-iodine solution be allowed to dry for three minutes, althoughin practice, particularly in emergency room situations, it is believedthat the solution typically may not be allowed to dry. The cathetertypically is sterile and may not be wiped with the povidone-iodinesolution.

The invention may be used in connection with the prior art techniques;normally by performing step 10 as described in FIG. 1 and then applyingthe povidone-iodine solution either before or after step 10. However,the skin cleansing solution applied in step 10 should not be rinsed withsterile water or otherwise.

Following application of the skin cleansing solution in step 10, andoptionally application of a 10% povidone-iodine solution or othersolution for use in sterile protocols, with the exception of sterilewater, which is not applied after step 10, the catheter is inserted intothe urethra. Additional sterile techniques should be practiced,including wearing gloves and the like as is well known to the person ofordinary skill in the art.

After catheter insertion, another soft, lint-free cloth that has beensaturated with the skin cleansing solution used in accordance with theinvention is wiped around the perineum in accordance with step 14,including the skin and contiguous exposed mucosa, and the exposedportions of the catheter, preferably in a downward direction. Again, asbefore insertion, wiping is accomplished front-to-back for women and inconcentric circles around glans penis for men.

Once insertion and immediate post-insertion catheter care has beenaccomplished, then catheter maintenance procedures are implemented usingthe skin cleansing solution in accordance with the invention as setforth in step 16. The catheter should be maintained by continuallyrepeating the application of the skin cleansing solution to the exposedarea of the catheter and the surrounding skin at least every 12 hours ormore frequently after insertion for the entire period of indwellingtime. Depending on specific circumstances or perhaps even an unaccountedcluster of CAUTI's, that time interval between maintenance steps may bereduced to 8, 6, or even 4 hours.

If, during the time the catheter is inserted, one or more incidents ofbowel incontinence or other specific contamination occurs, then thepatient, including the perineum and exposed portion of the catheter,should be thoroughly cleansed as soon as possible with the skincleansing solution and the regular, periodic, continual cleansingschedule resumed, all in accordance with step 18. A care decision can bemade at this point to reduce the time interval between maintenancesteps.

Once a determination has been made that catheterization is no longerrequired and that the catheter should be removed, then the skincleansing solution should, optionally, but preferably, be applied againimmediately prior to withdrawal to the exposed portions of the catheterand to the perineum as previously accomplished, in accordance with step20. Further in accordance with step 20, the skin cleansing solutionshould be applied again, optionally, but preferably, to the perineumimmediately after withdrawal, including the meatus, contiguous exposedmucosa, and surrounding skin of the perineum. Thereafter, the skincleansing solution should, optionally, but preferably, continue to beapplied to the perineum, including the meatus, contiguous exposedmucosa, and surrounding skin of the perineum until the danger ofinfection due to the presence of the catheter is considered to bepassed.

It should be recognized that removal of an indwelling catheter can leavemicro-abrasions and small tears in the delicate mucosal membranes of theurethra and meatus that provide sites for potential infection. Thus,CAUTI's are believed to occur even after a catheter is technically nolonger indwelling, demanding vigilance in treatment until the mucosa hasa chance to heal, typically from five to seven days, although treatmentcould continue for a month, if desired, without harmful side effectsfrom milder skin cleansing solutions preferred for use in the practiceof the method steps of the invention. Typically, post-withdrawaltreatment, at least after the initial catheter withdrawal, is performedby the patient in self-care in the home setting.

Turning now to a discussion of the skin in its barrier function, FIG. 2illustrates generally at 21 and in an exploded perspective view a highlyschematic section of the skin, including the outer layer, which is theepidermis 22, and the underlying dermis 24. FIG. 2 illustrates flow ofvarious substances through the epidermis to the dermis. At 26, the arrowillustrates the inability of soap and water even to penetrate theepidermis. At 30, the arrow illustrates chlorohexadrine gluconate'sability to create micro abrasions 28 in the epidermis and to penetratethe epidermis through to the dermis. Abrasions damage the skin and allowboth water loss as illustrated by the arrow at 32 and potential pathwaysfor infectious agents to penetrate the epidermis and enter the dermis,as illustrated by the arrow at 34.

Chlorohexadrine is not believed to be approved for use on exposedmucosa. Other approved antiseptic, antimicrobial, or antibacterialcompounds may be of similar impact in creating micro-abrasions. Althoughthese solutions could potentially be approved for use on mucosa and maythus be used in the practice of the method of the invention, it is notbelieved that these results would necessarily be equivalent and couldultimately create an environment prone to infection. It should beemphasized that milder solutions as discussed in detail below arepreferred, especially those capable of preserving the pH of the skin andits barrier and moisture qualities for an extended period of time, fromat least 3 to 12 hours.

Practice of the invention and adherence to catheter maintenance protocolis facilitated by supplying a preferred skincare cleansing solution inkits for sterile insertion of urinary catheters, along with instructionsfor use, including pre-insertion protocol, twice to six times dailymaintenance protocols while the catheter remains inserted, incontinenceprotocols, withdrawal protocols, and twice to six times dailypost-withdrawal protocols, as needed. Cloths typically are preferred foradministration of the cleanser, and two-cloth packs have proved usefulin trials of the method of the invention, although sprays and foams mayalso be used. When applying the cleanser from a cloth, it is useful tofold the cloth so as to use a clean fresh cloth surface for each wipe.

The steps of the method can be described as including both primary andsecondary decolonization of infectious agents. It should be recognizedthat by decolonization, what is being described is, as a primary matter,reducing the amount and type of infectious microbes on the skin whilemaintaining the skin's natural barrier properties, and, as a secondarymatter, continuing to maintain or support the skin's natural barrierproperties for an extended period of time, including the skin's acidicpH. Although the problem solved immediately herein is directedspecifically to CAUTI rates, it should be recognized that similarconcepts can also be applied to a number of different areas where activeinfections occur, including, but not limited to, the treatment of acne,wounds, and other areas of infection on the body, as well as other typesof catheters, including intravenous catheters, catheters used inveterinary medicine, decontamination of patients by bathing, and even todecontamination of environmental surfaces, although not necessarily withequivalent results. A modified method may be applied to decolonizepatients before they are moved to a new environment or to rooms before anew patient is admitted to the room and includes additional treatmentsas needed to insure that the opportunity for infection is reduced if noteliminated. Practice of this nature may be especially useful whentransferring patients from a hospital to a rehabilitation center, orfrom a nursing home to a hospital to interrupt the spread of CRE, MRSA,and VRE, which are known to be spread by contaminated patients and canspread infection throughout a hospital or skilled nursing facility andcan prove problematic to resolve.

Thus, the basic concepts behind the steps of the method of the inventionare suitable for other applications, including other types of indwellingcatheters, treatment of acne, which is in reality a small wound and siteof bacterial infection, and other wounds or for decolonization ofbacteria from entire persons or environments whereby bacterialinfections can be prevented or eliminated. These concepts can beincorporated into cleansing protocols using a solution such as isdescribed herein and the protocol altered as needed for continual,regular application of the solution for a sufficient period until theinfection or risk of infection has been cleared. Of course, it should berecognized that where no catheter is used, the steps of cleansing thecatheter, inserting the catheter, and maintaining the catheter will notbe implemented. In a specific embodiment, the skin or other surface iswiped with a cloth pre-moistened with the skincare cleansing agent.Typically, the cloths will be pre-moistened and pre-packaged non-wovenwipes. Foam cleansers are also useful and may be more economical.

Turning now to a discussion of the skin's acid mantle, maintaining theeffectiveness of the acid mantle promotes good skin health. A damagedacid mantle may lead to a number of skin complaints, such as, dry skin,flaky skin, oil overproduction, sensitivity, and acne. Products that donot facilitate the skin's natural pH can contribute to the degradationof the acid mantle, thereby increasing the likelihood that infectionscan develop. When the acid mantle is damaged, it can take up to 14 to 17hours to repair itself, and it is during this time that bacteria can beexpected to multiply more effectively. Thus, skin pH is an importantcomponent of effectively treating CAUTI's. Practice of the invention andcontinual adherence to its method to maintain the skin's pH isrecommended to reduce and prevent the occurrence and severity ofincidents of CAUTI.

The skin is comprised of three primary layers: the epidermis, which isthe outermost layer; an intermediate layer, the dermis, comprising hairfollicles, pores, sebaceous glands, sweat glands and connective tissue;and the hypodermis, which comprises an insulating fatty layer. Theoutermost layer, the stratum corneum (SC), is exposed to conditionsincluding temperature and humidity as well as various hygienic careproducts that can cause damage to this layer. The resulting damage oftencauses drying of the SC, which can cause the SC to crack, interfere withthe normal shedding of skin cells, and prevent the natural healing ofdamaged cells. The SC comprises dead skin cells and forms an importantbarrier layer protecting the underlying tissue from infection,dehydration, chemicals, and abrasion. Disruptions to the stratum corneumshould be avoided in protocols for indwelling catheter use.

Solutions that are used in connection with the protocols of theinvention should typically preserve the barrier function of the skin,components of which are an acidic pH mantle and sustained moisturecontent, in addition to optionally having antimicrobial and antisepticproperties that address the many types of bacteria that can causeCAUTI's. The acidic pH of the skincare solution used in the practice ofthe method of the invention can vary from as low as 4.0 to as high as6.5, which is the range of natural, uninfected skin. The solution ispreferably zwitterionic so as not to strip the naturally occurring andprotective lipids from the skin, therefore allowing the skin to stayhydrated. The solution is also antimicrobial and antiseptic and willtypically be non-antibiotic, unnecessary antibiotic use contributing toresistance in bacteria strains. It is especially useful if the solutionis capable of maintaining the balance of flora associated with normalskin, even if the quantity of flora is somewhat reduced. It is alsodesirable that the solution be easily absorbed through the epidermis andat least into the deep layers of the dermis in the absence of creatingmicro-abrasions that can provide an entry point for infectious agents.

Cleansing can be accomplished in accordance with the method steps of theinvention using a variety of skincare solutions. One aqueous skincaresolution that is effective in the practice of the invention isTHERAWORX® brand skin cleanser available from Avadim Technologies, Inc.in Asheville, N.C. THERAWORX® and similar skin cleansers are describedin U.S. Pat. No. 6,358,516, the contents of which are incorporatedherein by reference in their entirety.

The solutions for use in the practice of the invention desirably haveingredients for promoting zwitterionic surfactant properties that do notstrip the skin of lipids, antimicrobial or at least antisepticproperties, skin penetrating properties, and a mildly acidic pH similarto that of the natural state of the skin and capable of maintaining thenormal skin pH over an extended period of time from 3 to 12 hours andindefinitely via regular applications. Antibiotics need not typically beincorporated. Humectants and emollients and agents for promoting healingas taught in U.S. Pat. No. 6,358,516 are desirable.

A skincare and cleansing agent useful in the practice of the inventionmay include, as described in U.S. Pat. No. 6,358,516, among otheringredients:

(a) at least one surfactant;(b) at least one anti-inflammatory;(c) at least one anti-foaming agent;(d) at least one cell growth-promoting agent;(e) at least one fast-acting antimicrobial agent, each of saidingredients being skin-compatible and different from the otheringredients of said composition; and at least one different ingredientselected from the group of:(f) immune system-enhancing agents, wherein at least one immunesystem-enhancing agent is aloe vera, beta glucan, colloidal silver, orallantoin;(g) absorption facilitation agents, where in at least one absorptionfacilitating agent is beta glucan, aloe vera, or colloidal silver;(h) humectants and emollients, wherein at least one humectant oremollient is aloe vera, vitamin E, or cocamidopropyl;(i) free radical-scavenging agents, wherein at least one freeradical-scavenging agent is a bioflavonoid, a polyphenolic compound, agrapefruit-derived quaternary compound, beta glucan, allantoin, vitaminE, pycnogenol, or grape seed extract; and(j) healing promoting agents, wherein said ingredients are selected toform a stable, no-rinse, radiation-sterilizable composition thatair-dries quickly when applied to the skin and that cleanses,therapeutically conditions, and treats the skin in a one-stepapplication, wherein at least one healing-promoting agent is aloe vera,allantoin, or beta glucan. It should be recognized that where a compoundis mentioned in two different categories that the compound serves bothfunctions in the formulation and that each function is present when thecompound is present.

Cleansing agents are surfactants, including soaps, including, but notlimited to, amphoteric surfactants, which are surfactants having thecapacity of behaving either as an acid or a base, including, forexample, cocamidopropyl betain, alkyl polyglucosides, lauryl glucoside,and combinations thereof. Reddened skin is the first sign of aninfection and other skin problems, and indicates that the skin isredirecting its natural resources from growth and other normal functionsto prevention and repair. Reducing or eliminating reddening may increasethe growth of healthier new skin. Anti-inflammatory agents includeagents that known to reduce skin reddening, including, but not limitedto aloe vera, allantoin, cocamidopropyl betain, beta glucan, andcombinations thereof, in amounts shown to be effective during cleansing.Skin-compatible anti-foaming agents include silicone-based antifoamingagents, dimethicone copolyol, and the like. When present in thepreferred combinations and concentrations, growth-promoting agentspromote or stimulate new skin growth and promote healing ofsignificantly greater magnitude than previously observed. Agents thatstimulate or promote cell growth, including but not limited to aloevera, allantoin, which is glyocyldiureide or 5-ureidohydantoin, betaglucan, polyphenolic compounds such as Citricidal®, and combinationsthereof. Citricidal® and like compounds have been demonstrated to beeffective against a broad spectrum of bacteria. These compounds containquaternary compounds derived from grapefruit or other bioflavonoidstogether with inert ingredients such as glycerin.

Agents that enhance or stimulate the skin's immune system or helpprovide a secondary immune system, include but are not limited to aloevera, beta glucan, colloidal silver, allantoin, and combinationsthereof. When present in the composition in the preferred quantities,these agents promote healing and also help reduce the incidence ofinfections.

Colloidal silver, Citricidal®, beta glucan, aloe vera, and likeingredients are believed to have therapeutic value to promote andstimulate the existing immune system to help reduce infections andpromote healing. Colloidal silver and Citricidal® support the naturalimmune system by reducing its workload; Citricidal® is also believed topromote healing by a mechanism which is yet unclear.

Beta glucan, which is a D-glucose polymer also known as beta-1, extractor yeast derivative, is a non-specific immune stimulator that alsoexhibits free-radical scavenging activity. Beta glucan stimulates thebody's immune system T-cells; mannoproteins and polysaccharides such asaloe vera provide the T-cells to be effective. A mannoprotein is asugar-protein, a glycoprotein, that is linked to beta glucan in yeastand barley cell walls. Mannoproteins directly increase the structuralintegrity, alertness and numbers of immune cells. Fast-acting,skin-compatible antimicrobial agents are effective against at least oneor all of bacteria, viruses, yeasts, and fungi, and include, but notlimited to colloidal silver, Citricidal®, pycnogenol, grape seedextract, antibiotics, and combinations thereof, in effective amounts tokill infectious organisms, including bacteria, viruses, yeasts, andfungi on and in the skin during skin cleansing and upon drying.

The skin harbors a wide variety of microorganisms; some of these arepotentially harmful while others are beneficial. Ideally, this normalbacterial flora is not destroyed by cleansing. However, a cleanser thatreduces the accumulation of bacteria and fungi present on the skin helpsreduce the incidence of infections, especially in a hospitalenvironment. The selected antimicrobial agent or agents is fast-acting,so as to act against bacteria, fungi, and the like microorganisms. Theaction of the antimicrobial agent or agents during cleansing and rapidair drying substantially kills viruses, bacteria, fungi, and yeastspresent in the living basal cell layer and the dermis of the skin inaddition to those transferred onto or living in the dead horny layer orepidermis. This action serves to reduce the occurrence or severity ofinfections due to bacteria, viruses, and the like infectiousmicroorganisms entering breaks in the skin, whether small tears or microabrasions.

Some antimicrobial agents, such as colloidal silver and Citricidal®, arecompatible with normal flora, capable of penetrating into the dermis,and also provide useful antimicrobial properties. Colloidal silver killssingle cell microorganisms such as bacteria by penetrating their cellwalls in a manner similar to the body's T-cells. Therefore, theseorganisms cannot mutate into resistant strains as they do with manyother antimicrobial agents. However, colloidal silver has limitedpotency and must preferably be supplemented with other antimicrobialagents in formulating a composition according to the invention. Inaddition, the colloidal silver is preferably formulated with particlesthat are small enough to penetrate the dermis, which is approximately0.005-0.02 microns, and, more preferably, approximately 0.01-0.1microns.

Numerous studies have demonstrated that Citricidal® has many unique anddesirable antimicrobial properties, including at least someeffectiveness against HIV, hepatitis and other viruses, and a wide rangeof bacteria, fungi, and yeasts, while being highly biocompatible andproviding other benefits to the skin.

Tests show that a combination of 2% or less Citricidal® and other agentssuch as colloidal silver is approximately 99.9% or more effective inkilling the harmful microorganisms usually present in the skin, andprevalent in medical institutions.

Compatible humectants and emollients, including but not limited to aloevera, allantoin, vitamin E (tocopherol), beta glucan, cocamidopropylbetain, and combinations thereof. These agents naturally re-moisturizethe dead horny layer, epidermis, and/or dermis without clogging pores.

Humectants and emollients in the composition act to naturallyremoisturize the skin surface (i.e., the dermis) to prevent dryness,increase elasticity, reduce the incidence of skin tears, and supplementthe activity of the sebaceous glands to reproduce oils without cloggingpores. Over usage of humectants and/or emollients is a major cause ofskin eruptions, inflammation, and acne, therefore, simply increasing theamounts of humectants and/or emulsifiers to provide a longer lastingprotective barrier can promote skin problems. Therefore, the amounts ofthese ingredients are controlled so as to minimize undesirable effects,particularly regarding the perineum and meatus.

Agents that scavenge free radicals and help detoxify the skin, includingbut not limited to Citricidal®, beta glucan, allantoin, vitamin E,pycnogenol, grape seed extract, and combinations thereof. Agents thatpromote and/or stimulate new skin growth and skin healing, including butnot limited to ale vera, allantoin, Citricidal®, beta glucan,pharmaceuticals, and combinations thereof. Biocompatible preservatives,including but not limited to methylparaben, propylparaben,ethylenediaminetetraacetic acid, which is referred to as EDTA, and likeagents and combinations thereof. Biocompatible fragrances, including butnot limited to natural orange, lemon, lavender, and combinationsthereof. Other beneficial agents, including but not limited to thosecontaining vitamins and vitamin precursors, including vitamin A,carotene, cryptoxanthin, retinol, 3-dehydroretinol, vitamin C orabsorbic acid, vitamin E or tocopherol, and the like, herbs, includingchamomile, lavender, ginseng, ginkgo, and the like, and antioxidants,collagens, pH-balancing agents, and combinations thereof. Eachingredient of the composition is present in an amount that, as apercentage of the total weight of the composition, is effective eitheralone or synergistically with the other ingredients to achieve thedesired results.

The following examples are provided in support, but not in limitation,of the invention.

EXAMPLES Example 1

A trial was conducted at First Health Moore County Regional Hospital, a395 bed facility, in Pinehurst, N.C. from August to October 2013. Priorto the trial, First Health's CAUTI rate was similar to other similarsize hospitals in North Carolina. After reviewing the CAUTI's thatoccurred at First Health, it was discovered that the majority of CAUTI'soccurred after a Foley catheter had been in place for greater than 5days, which lead the hospital to believe that it had issues with thecare and maintenance of catheters. The hospital then used Theraworx®brand solutions in July of 2013 in its intensive care unit, or ICU, andbegan the trial in August. Hospital personnel were directed to applyTheraworx® brand solution to the perineum as a pretreatment step, bothbefore and immediately after insertion as described hereinabove and toimplement a maintenance treatment step every 8 hours while the catheterwas inserted.

In the same time period a year earlier the hospital had 4 CAUTI's in theICU for 1728 catheter days for a rate of 2.3 infections per 1000catheter days. During the trial in which Theraworx® brand solution wasused in accordance with the invention, the hospital had 0 CAUTI's in theICU over 1667 catheter days, which is a rate of 0 infections per 1000catheter days.

The results of this study were reviewed by hospital ICU staff and theprotocol was approved for hospital wide implementation, despite thecurrent best practice recommended in the most recent literature of soapand water.

The policies for catheter insertion and catheter care were reviewed,best evidence based practice was reviewed, and the hospital's policiesand protocols were revised in December 2013 for staff to performcatheter care prior to and immediately after insertion and every 8 hoursthereafter for the period of indwelling using Theraworx® brand foamcleanser on cloths applied to the perineum and catheter, including theadditional step of wiping the perineum with Theraworx® brand cleanserafter removal of the catheter.

Example 2

A trial, using the Theraworx solution, was conducted at five intensivecare units at Baptist Hospital, a 383 bed facility in Lexington, Ky. Thepurpose of the hospital study was to determine whether the use of acolloidal silver impregnated wipe and foam cleanser, which was theTheraworx® brand solution, when used as part of a cleansing protocolwithin the current Foley catheter care protocol practiced by thehospital would be efficacious in reducing the incidence of CAUTI's inthe intensive care setting.

Mean infection rates in the five ICU's in 2012 ranged from 1.2infections per 1000 device days to 5.9 infections per 1000 device days.The hospital performed the steps of the protocol starting in April 2013,including cleansing the perineum prior to insertion with Theraworx® andallowing the solution to dry in air for 30 seconds, opening the sterileFoley catheter and cleansing the Foley catheter with Theraworx®, wipingthe meatus with Betadine®, and inserting he catheter using the acceptedaseptic techniques. The meatus, perineum, and exposed portions of thecatheter were again cleansed with Theraworx® after insertion. Theraworx®soaked cloths were used two to three times daily for maintenance wipingand additional wiping was done as a final cleansing for incontinence. Asa result, zero CAUTI's were reported in four out of five ICU's by thesecond month of the study and by the fourth month all five ICU's hadreduced their CAUTI infections to zero infections per 1,000 device.Although some units had achieved zero CAUTI infection rates prior to thestart of the study, it was only after the study was initiated that allfive intensive care units maintained a zero CAUTI infection rate for thesame month. These results exceeded the 2012 mean CAUTI rates and werebelow the National Healthcare Safety Network CAUTI benchmark of 1.4infections per 1,000 device days.

Table 1, below, summarizes the results of the hospital study from June2013 through July 2013 and includes the rates of CAUTI's of each of thefive ICU's from January 2013 through July 2013 and the 2012 mean rate ofCAUTI's in each of the five ICU's. The corresponding results areillustrated graphically in FIG. 3.

TABLE 1 2012 Mean January February March April May June July 2ICU CAUTIRate (per 1,000 device days) 2.3 5.6 0 11.2 6.8 6.6 0 0 3IN CAUTI Rate(per 1,000 device days) 1.2 0 0 0 0 0 0 0 3IS CAUTI Rate (per 1,000device days) 4.7 0 9.8 0 0 0 0 0 4IN CAUTI Rate (per 1,000 device days)5.9 13.5 0 0 0 0 0 0 4IS CAUTI Rate (per 1,000 device days) 0.9 0 0 0 00 0 0 NHSN CAUTI Benchmark 1.3 1.4 1.4 1.4 1.4 1.4 1.4 1.4

The hospital report also details information collected on the 1,282patients over a three month period related to: (a) risk factorsassociated with CAUTIs, and (b) nurse behaviors related to care of Foleycatheters. Data were collected for each patient for a period of 1 to 10days depending on length of stay. Descriptive statistics were calculatedin order to evaluate potential risk factors for CAUTI's, including age,gender, weight, stool incontinence, and related nursing practices amongpatients in critical care.

It should be recognized that sometimes an ICU held few catheterizedpatients and that multiple variables can impact CAUTI rate, includingstaff compliance with established protocol. For example, where there arefew catheterized patients in the ICU, the CAUTI rate may fall to zero.However, overall, the impact of the protocol of the method of theinvention is clearly demonstrated to reduce CAUTI rates and to increasecompliance with the new protocol as compared to established protocol.

In order to evaluate nursing practice of Foley care, the followingquestions were asked of the nurses: 1) was Theraworx® used to clean theperineum? 2) was Theraworx® used to clean the Foley catheter? 3) werethe components of the catheter accurately attached? and 4) was the Foleycatheter accurately placed? The information relating to nursing practiceof Foley care is summarized below in Table 2. The letter “n” refers tothe number of device indwelling days.

TABLE 2 Theraworx used Accurate Accurate to cleanse Theraworx usedattachment of placement of the Perineum to cleanse Foley the deviceFoley Day in Hospital Yes(n) Yes (n) Yes(n) Yes(n) 1  99.1% (1,099) 99.8% (1,238)  99.4% (1,238)  99.8% (1,241) 2  98.8% (811) 100.0% (872) 99.9% (874)  99.9% (869) 3  99.7% (385)  99.8% (421)  99.8% (422)100.0% (422) 4  97.8% (223)  99.6% (241)  99.2% (241) 100.0% (241) 5100.0% (113) 100.0% (121) 100.0% (120) 100.0% (120) 6 100.0% (56) 100.0%(59) 100.0% (59) 100.0% (59) 7 100.0% (15) 100.0% (15) 100.0% (15)100.0% (15) 8 100.0% (5) 100.0% (5) 100.0% (5) 100.0% (5) 9 100.0% (3)100.0% (3) 100.0% (3) 100.0% (3) 10 no data no data no data no data

Example 3

John Muir Medical Center in Walnut Creek, Calif., undertook a study as aquality improvement project in its emergency department, the studyundertaken from April 2013 to Jul. 10, 2014, to evaluate the impact ofTheraworx® brand antiseptic used in protocols for urinary catheterinsertion and maintenance for CAUTI prevention in hospitalized patients.CAUTI's were defined according to the definitions of the Centers forDisease Control and Prevention National Heathcare Safety Network. TheJohn Muir study specifically refers to the Prevention Guidelines of theHealthcare Infection Control Practices Advisory Committee (HICPAC) andto Gould C. V., Umscheid C. A., Agarwal R. K., et al.

The “Guideline for Prevention of Catheter-Associated Urinary TractInfections 2009,” which was accessed by John Muir Medical Center in2014, recommends, in contrast to the method of the invention studied atJohn Muir and the subject matter of the invention described herein, thatantiseptic solutions not be used for routine catheter maintenance due toa lack of evidence to make an evidence-based decision. However, cleaningthe periurethral area with antiseptics is recommended.

The John Muir Medical Center Study concluded that clear trends wereevident shortly after use of the full Theraworx protocol was implementedthat may show an effective CAUTI prevention intervention once fullyimplemented that is guideline concordant and fills critical gaps inknowledge.

The John Muir Medical Center protocol included using a cloth impregnatedwith Theraworx® brand antiseptic to wipe the perineum before Foleycatheter insertion, concentrating on the entrance to the meatus, wipingfront-to-back for women and in concentric circles around the glans penisfor men. This first application was allowed to dry for thirty secondsand not rinsed off. Thereafter, the Foley catheter kit was opened, aBetadine® brand antiseptic swab was used to cleanse the urinary meatusarea and the Foley catheter was inserted while practicing acceptedsterile techniques. A new, second cloth impregnated with Theraworx®brand antiseptic was used to wipe around the meatus and catheter in adownward direction for post-insertion catheter care, again wipingfront-to-back for women and in concentric circles around the glans penisfor men. Thereafter, new fresh wipes or a foam solution applied to aclean washcloth were used for routine catheter care and frequentperineum care every 8 to 12 hours, all in accordance with the invention,and for final cleaning after each incidence of incontinence or othercontaminating event. In the event high risk factors were identified,then maintenance was increased to every four hours until the catheterwas removed.

FIG. 4 graphically illustrates the CAUTI rate per catheter day by monthat the Walnut Creek facility for the period of the trial. FIG. 5graphically illustrates the days between CAUTI's over time, by month.

John Muir Medical Center reported that use of the Theraworx® impregnatedcloths in connection with improvement in nursing staff behaviorsdrastically reduced the number of insertion-related CAUTI's, which areCAUTI's in which a UTI is not present on admission and a positive urineculture develops on or before the third day after insertion. In the fourmonths after the improvements in quality were implemented, the number ofdocumented emergency department related CAUTI went from 3 to less than1.5 and costs dropped commensurately. In one month, the number ofCAUTI's was zero, and no costs attributable to CAUTI were incurred.

Example 4

Euclid Hospital, a hospital in the Cleveland Clinic Hospital system,Cleveland Ohio, undertook a quality improvement project similar to thatof John Muir Medical Center from June through August 2014, although Junewas considered to have been used for training in the protocol of theinvention. The CAUTI rate from January 2013 to August 2014 isgraphically illustrated in FIG. 6 as the result of a statisticalanalysis. Euclid Hospital stated that Theraworx® antiseptic solution andthe protocol of the invention may be an effective CAUTI preventionintervention and that Theraworx® antiseptic's benefits over otherantiseptics includes a broad spectrum of activity, ability to maintainthe skin's natural pH, which is to say to protect the stratum corneum,and sufficiently mild for use in the peri-rectal areas and on mucusmembranes. Although no special cause variation was identified on thestatistical process control chart, FIG. 6, Euclid Hospital was able toreach and maintain zero CAUTI after implementation of the protocol ofthe invention.

Antiseptic solutions for use in the practice of the invention, includingTheraworx® brand antiseptic cleanser, unlike cholorohexadrine andalcohol, have no restrictions for application to the face, mucusmembranes, the meatus, or perineal and rectal areas, and may be used asfrequently as deemed necessary. Formulations of this nature havebroad-spectrum antimicrobial activity, anti-yeast and anti-fungalproperties, while nourishing and moisturizing the skin, maintaining thenatural pH of the skin's mantel, supporting the stratum corneum so thatbarrier function is preserved even as the skin is decolonized frominfectious agents. Prolonged antimicrobial activity is demonstrated upto about three hours. It should be noted that odors are also oneindication of infection and that practice of the method of the inventionreduces or eliminates odors associated with CAUTI's. The mode ofbacterial cellular death is believed to be disruption of cell membraneswith the resultant loss of cytoplasmic contents and yet without damageto skin or living tissues. Three substances are believe to contribute:citrus-based antimicrobial stabilizers, zwitterionic surfactants withquaternary ammonium cations, and colloidal silver. The formulationcontains vitamin E, aloe vera, allantoin, colloidal silver, and betaglucan 1, and is said to be greater than 99.9% effective against gramnegative and gram positive bacteria.

The invention is defined as set forth in the appended claims.

What is claimed is:
 1. A method for the reducing the incidence ofcatheter associated urinary tract infections (CAUTI's), comprising thesteps of: a. wiping the perineum, meatus, and contiguous mucosasurrounding a urethral insertion site with a solution comprising atleast one antiseptic skin cleansing agent additionally having propertiesof supporting the barrier function of the stratum corneum; b. wiping acatheter body with a solution of subpart (a); c. inserting the catheterinto the urethra; d. wiping the exposed portion of the inserted catheteralong with the perineum, meatus, and contiguous mucosa surrounding theinsertion site immediately after insertion and in a downward directionwith the solution of subpart (a); e. wiping the perineum, meatus, andcontiguous mucosa surrounding the insertion site periodically at leastevery 12 hours for the period of indwelling of the catheter with thesolution of subpart (a).
 2. The method of claim 1 further comprisingwiping the urinary meatus with a povidone-iodine solution beforeinserting the catheter in accordance with step (c).
 3. The method ofclaim 1 wherein the skin and contiguous mucosa comprise the perineum andthe urethral insertion site comprises the meatus.
 4. The method of claim1 wherein the solution is characterized as non-antibiotic, zwitterionic,antimicrobial, and having a pH of from 4.4 to 5.5.
 5. The method ofclaim 4 wherein the solution comprises citrus-based antimicrobialstabilizers, zwitterionic surfactants with quaternary ammonium ions, andcolloidal silver.
 6. The method of claim 1 wherein the solution has a pHof from about 4.7 to 5.5.
 7. The method of claim 1 wherein the solutionis an aqueous composition comprising at least one surfactant, at leastone anti-inflammatory agent, at least one non-foaming agent, at leastone cell growth promoting agent, at least one fast acting antimicrobialagent, and at least one different ingredient selected from the groupconsisting of immune system enhancing agents, absorption facilitatingagents, humectants and emollients, free radical scavenging agents, andhealing promoting agents.
 8. The method of claim 1 in which the wipingstep (e) is repeated after insertion about every 6 to 8 hours.
 9. Themethod of claim 1 wherein the wiping step (e) is repeated afterinsertion about every 4 hours.
 10. The method of claim 1 furthercomprising the steps of wiping the exposed portion of the catheter,perineum, meatus, and contiguous mucosa with the solution immediatelyprior to catheter removal, removing the catheter, and thereafter wipingthe perineum, meatus, and contiguous mucosa with the solutionimmediately after catheter removal.
 11. The method of claim 10 furthercomprising the steps wiping the perineum, meatus, and contiguous mucosawith the solution after removing the catheter about every 6 to 12 hoursuntil the threat of CAUTI has passed.
 12. The method of claim 11 whereinthe threat of CAUTI has passed in 5 to 7 days.
 13. In a method for themaintenance of urethral catheters in which the meatus is treated withpovidone-iodine solution prior to insertion of the catheter to reducethe incidence of a catheter associated urinary tract infection (CAUTI),the improvement comprising: a. cleansing the catheter and the perineum,including the urinary meatus and contiguous mucosa, with anon-antibiotic, zwitterionic, mildly acidic, antiseptic solution priorto treatment with povidone-iodine solution; b. inserting the catheterusing sterile technique; c. cleansing the exposed portion of thecatheter and the perineum immediately after insertion with theantiseptic solution; d. cleansing the exposed portion of the catheterand the perineum with the antiseptic solution periodically afterinsertion about every 6 to 12 hours for the duration of indwelling; e.repeating step (c) immediately prior to removal of the catheter; f.removing the catheter; and g. cleansing the perineum with the antisepticskincare solution after removal every 6 to 12 hours until the likelihoodhas passed of the occurrence of a CAUTI.
 14. The method of claim 13further comprising the step of providing a patient having his or hercatheter removed with a kit for home self-care for accomplishing step(g) by periodically applying the antiseptic skincare solution aboutevery 6 to 12 hours for up to a month.
 15. The method of claim 13wherein the antiseptic solution has a pH of from about 4.4 to 5.5. 16.The method of claim 13 further comprising cleaning the patient,including the perineum, urinary meatus, contiguous mucosa, and exposedportions of the catheter after an incidence of incontinence or othercontamination.
 17. The method of claim 13 wherein step (d) is performedevery 4 hours in the event of the occurrence of risk factors.
 18. Amethod for decontaminating a mammal to reduce the opportunity for spreadof infectious agents by bathing the mammal with a non-antibiotic,zwitterionic, mildly acidic, antiseptic solution.
 19. A method forreducing the incidence of infection in the use of catheters comprisingthe steps of: a. wiping a catheter surface and the area surrounding theinsertion site with a solution comprising at least one skin cleansingagent that is non-antibiotic, zwitterionic, mildly acidic, andantiseptic prior to treatment with povidone-iodine solution; b.inserting the catheter cleansed in accordance with step (a) into theinsertion site also cleansed in accordance with step (a); c. wiping theexposed portion of the inserted catheter and the skin surrounding theinsertion site immediately after insertion with the at least one skincleansing agent; and d. wiping the skin surrounding the insertion siteperiodically at least every 12 hours for the period of indwelling of thecatheter with the at least one skin cleansing agent.
 20. The method ofclaim 19 further comprising the step of wiping the exposed portion ofthe inserted catheter and the skin surrounding the insertion siteimmediately prior to withdrawal of the catheter with the skin cleansingagent.